Alcohol Use DisorderPhase 2NCT04466215
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
A Phase 2 study testing Miricorilant in people with Alcohol Use Disorder, run by The Scripps Research Institute at 1 site in United States.
Trial summary
The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Miricorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 7 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers, 18-75 years of age.
- Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).
- Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues.
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.
- In acceptable health in the judgment of the study physician, based on interview, medical history, physical exam, ECG, routine urine and blood chemistry.
- Subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current DSM-5 criteria for depression or anxiety.
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- All subjects must agree to use double barrier birth control for the study duration and one month thereafter i.e., males must use condoms and females must use spermicide and/or a non hormonal barrier method, and their opposite sex partner must likewise use an effective non hormonal form of contraception.
- Able to provide informed consent and understand questionnaires and study procedures in English.
- Willing to comply with the provisions of the protocol and take daily oral medication
Who cannot join
- Medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism.
- Clinically significant findings on physical exam, ECG, urine or blood tests that may increase risk.
- CYP2C19 inhibitors
- Substrates metabolized primarily by CYP3A, CYP2C9, and CYP2C8 with narrow therapeutic index
- BCRP and UGT1A1 substrates
- Meets DSM-5 criteria for a current major psychiatric disorder, including mood, anxiety or substance use disorders, other than alcohol, nicotine, or mild cannabis use disorders.
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- Pregnant or lactating.
- Treatment within the month prior to screening with (1) an investigational drug, (2) drugs which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate [Campral], or anticonvulsants.
- Chronic systemic steroid use
- Using drugs that are strong inhibitors and inducers of CYP2C9.
- No fixed domicile and/or no availability by home or mobile telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, 92037
About this study
The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
- Conditions
- Alcohol Use Disorder
- Being tested
- Miricorilant, Placebo oral tablet
- Keywords
- Alcohol-Related Disorders
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiricorilantDrug
Also called CORT118335
900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
Placebo oral tabletDrug
Also called Sugar pill
Six placebo tablets taken orally once daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Miricorilant | Active comparator | 900 mg (6 x 150 mg) tablets daily taken orally for two weeks Receives: Drug: Miricorilant |
| Placebo | Placebo comparator | Six placebo tablets taken orally for two weeks Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving to Drink
Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
Measured: 1 hour on the last day of dosing (Day 14)
Secondary outcomes (1)
Drinking
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.
Treatment effects on drinking were assessed during the 11 days of ad libitum drinking and did not include the final three days of mandatory abstinence prior to cue reactivity session.
Measured: 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Apr 2021
- Primary completion15 Apr 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, Double-Blind, Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Barbara J. Mason, Ph.D., Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466215
- Sponsor's protocol ID
- NIAAAMAS006420
- Other IDs
- U01AA025476
- Status last verified
- Jan 2023
- First submitted
- 6 Jul 2020
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
- ClinicalTrials.gov ID
- NCT04466215
- Acronym / sponsor ID
- NIAAAMAS006420
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment, Double-Blind, Randomized
| Arm | Type | Receives |
|---|---|---|
| Miricorilant | Active comparator | Drug: Miricorilant900 mg (6 x 150 mg) tablets daily taken orally for two weeks |
| Placebo | Placebo comparator | Drug: Placebo oral tabletSix placebo tablets taken orally for two weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female volunteers, 18-75 years of age.
- Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).
- Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues.
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.
- In acceptable health in the judgment of the study physician, based on interview, medical history, physical exam, ECG, routine urine and blood chemistry.
Key exclusion criteria (11 listed)
- Medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism.
- Clinically significant findings on physical exam, ECG, urine or blood tests that may increase risk.
- CYP2C19 inhibitors
- Substrates metabolized primarily by CYP3A, CYP2C9, and CYP2C8 with narrow therapeutic index
- BCRP and UGT1A1 substrates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiricorilantAlso: CORT118335900 mg (6 x 150 mg) tablets taken orally once daily for two weeks | Drug | Miricorilant |
| Placebo oral tabletAlso: Sugar pillSix placebo tablets taken orally once daily for two weeks | Drug | Placebo |
Primary outcome
Craving to Drink
Time frame: 1 hour on the last day of dosing (Day 14)
Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
1 secondary outcome
Drinking
Time frame: 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J. Mason, Ph.D. principal investigator
The Scripps Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miricorilant in people with Alcohol Use Disorder, run by The Scripps Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving to Drink (time frame: 1 hour on the last day of dosing (Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.